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Trial registered on ANZCTR


Registration number
ACTRN12624000366550
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting haemostasis for central venous access devices: a randomised controlled trial
Scientific title
Promoting haemostasis for central venous access devices: a comparison of Statseal products with standard dressing care in adult inpatients to assess impact on dressing failure.
Secondary ID [1] 310480 0
None
Universal Trial Number (UTN)
Trial acronym
PRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device - associated bleeding 331269 0
Central Venous Access Device - dressing failure 331825 0
Central Venous Access Device - infection 331826 0
Condition category
Condition code
Public Health 328023 328023 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm:
StatSeal (potassium ferrate) disc or powder (Biolife, Sarasota, Florida), plus site-specific securement and dressing, see below. Application of disc vs powder will be at clinician discretion. The clinician (doctor or nurse) inserting the device will apply the StatSeal product. StatSeal will only be applied once at the application of the initial dressing. Appropriate application of the intervention will be monitored by the research nurse.

Liverpool Hospital (Site 1):
Securement (e.g. StatLock, SecurAcath or suture)
Dressing (e.g. 'Tegaderm CHG' (chlorhexidine gluconate) dressing)

Royal Brisbane and Women's Hospital (Site 2):
Securement (e.g. Statlock)
Dressing (e.g. 'Tegaderm IV Advanced' + 'Biopatch disc')
Intervention code [1] 326868 0
Prevention
Comparator / control treatment
Control arm (no StatSeal products - standard dressing/securement only):

Liverpool Hospital (Site 1):
Securement (e.g. StatLock, SecurAcath or suture)
Dressing (e.g. 'Tegaderm CHG' (chlorhexidine gluconate) dressing)

Royal Brisbane and Women's Hospital (Site 2):
Securement (e.g. Statlock)
Dressing (e.g. 'Tegaderm IV Advanced' + 'Biopatch disc')
Control group
Active

Outcomes
Primary outcome [1] 335896 0
The requirement for the initial central venous access device (CVAD) dressing to be replaced due to evidence of bleeding, blood staining and/or soiling or loose/lifting edges before the scheduled dressing change on day 7 post-CVAD insertion.

Requirements for the initial dressing to be changed prior to 7 days will be determined by clinical staff.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician who changed the dressing; or on review of paper or electronic medical records.
Timepoint [1] 335896 0
Assessed daily from CVAD insertion up to any day prior to Day 7 post-CVAD insertion.
Secondary outcome [1] 426053 0
Central line-associated bloodstream infection (CLABSI): as defined by the National Healthcare Safety Network (NHSN) 2023 criteria.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [1] 426053 0
Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
Secondary outcome [2] 426054 0
Primary Blood Stream Infection (BSI): as defined by NHSN 2023 criteria.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [2] 426054 0
Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
Secondary outcome [3] 426055 0
All-cause CVAD dressing failure: a composite measure of dressing failure resulting from a compromised CVAD dressing requiring a dressing change, for any reason, before the scheduled dressing change on day 7 post-CVAD insertion.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician who changed the dressing; or on review of paper or electronic medical records.
Timepoint [3] 426055 0
Assessed daily from CVAD insertion up to any day prior to Day 7 post-CVAD insertion.
Secondary outcome [4] 426056 0
Local infection: Localised insertion site infection (without bloodstream infection) as per NHSN 2023 criteria.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [4] 426056 0
Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
Secondary outcome [5] 426057 0
Patient reported acceptability of the dressing product at application and removal.

Assessed by the Research Nurse after the initial application of the dressing and on dressing removal. Measured on a verbal scale (0 - not satisfied at all, to 10 - completely satisfied)
Timepoint [5] 426057 0
After application of the allocated study dressing and on removal of the allocated study dressing.
Secondary outcome [6] 426058 0
Serious adverse events (death, central line-associated bloodstream infection (CLABSI), central venous access device-associated skin impairment (CASI), allergic dermatitis, pressure injury stage 2 or greater)

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [6] 426058 0
Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
Secondary outcome [7] 426061 0
Central venous access device (CVAD) catheter migration: defined as catheter migration of more than 2 centimetres in or out of the skin from the original insertion depth.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [7] 426061 0
Assessed daily from CVAD insertion until the study dressing is removed.
Secondary outcome [8] 426062 0
Adverse events: skin outcomes including CVAD-associated skin impairment (CASI). For example, allergic dermatitis, significant contact dermatitis or pressure injury (greater or equal to stage 2) at the site.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [8] 426062 0
Assessed daily from CVAD insertion until the study dressing is removed.
Secondary outcome [9] 426063 0
Central venous access device (CVAD) failure: all-cause composite measure of failure resulting from pain, infiltration/extravasation, blockage/occlusion (with or without leakage), fracture, thrombosis (symptomatic or confirmed), dislodgement (complete or partial) or infection.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [9] 426063 0
Assessed daily from CVAD insertion until the study dressing is removed.
Secondary outcome [10] 426064 0
Number of dressing changes per patient.

This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
Timepoint [10] 426064 0
During the first 7 days post-CVAD insertion.
Secondary outcome [11] 428093 0
Cost: (products, staffing time and cost of complications). This information will be calculated based on staff estimates and expert opinion. Costs of treating complications will be based on standard local diagnosis related groups and published estimates (Tuffaha et al, 2019, Australian Health Review 43; 511-515).
Timepoint [11] 428093 0
During first 7 days post-CVAD insertion.
Secondary outcome [12] 432035 0
Staff reported acceptability of the dressing product at application and removal.

Assessed by the Research Nurse after the initial application of the dressing and on dressing removal. Measured on a verbal scale (0 - not satisfied at all, to 10 - completely satisfied)
Timepoint [12] 432035 0
After application of the allocated study dressing and on removal of the allocated study dressing.

Eligibility
Key inclusion criteria
Patient is
1. 18 years or older
2. Expected to require a CVAD for 48 hours or more
3. Currently an admitted patient or expected to be admitted to the hospital within 24 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has
1. Burned or scarred skin at the CVAD insertion site
2. A known allergy to Chlorhexidine, potassium ferrate, or transparent dressing adhesives
3. Been commenced on end-of-life pathway
4. Previously enrolled in this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be via a central, web-based service (1:1) with allocation concealment until commencement of study procedures
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated in a ratio of 1:1 (control to intervention) with randomly varied permuted block sizes of between 6 and 10. Randomisation will be stratified by recruiting site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 25756 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 25757 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 41582 0
2170 - Liverpool
Recruitment postcode(s) [2] 41583 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 314682 0
University
Name [1] 314682 0
University of Wollongong
Country [1] 314682 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 316652 0
None
Name [1] 316652 0
Address [1] 316652 0
Country [1] 316652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313699 0
Metro North health Human research Ethics Committee B
Ethics committee address [1] 313699 0
Metro North Human Research Ethics Committee B, Building 14, Rode Road, Chermside, Queensland, 4032
Ethics committee country [1] 313699 0
Australia
Date submitted for ethics approval [1] 313699 0
04/09/2023
Approval date [1] 313699 0
20/10/2023
Ethics approval number [1] 313699 0
HREC/2023/MNHB/101214

Summary
Brief summary
When a central venous access device (CVAD – incorporates both centrally and peripherally inserted central catheters) is inserted, it breaches the body’s protective barrier – the skin. Together with the patient’s intrinsic risk factors associated with their illness (e.g., cancer and deranged metabolic function such as in critical illness), this places them at risk of persistent bleeding at the catheter exit site and systemic infections. These complications are highly correlated; bleeding at the insertion site causes dressing disruption, which is associated with an increased risk for central line-associated bloodstream infections (CLABSI).

Potassium ferrate haemostatic discs and powder (StatSeal®, Biolife, Sarasota, Florida) contain a strong haemostatic agent which has primarily been used to promote haemostasis post-interventional vascular procedures and interventional cardiology. The haemostatic disc and powder also has the option of being applied at the CVAD skin exit site, however, its role to prevent haemostasis and promote dressing integrity (thereby reducing the risk of infection with longer-dwelling venous access devices), is yet to be explored.

To provide further evidence and inform clinical practice, it is important to address this evidence-practice gap and test the safety and efficacy of the potassium ferrate products in promoting haemostasis and preventing dressing disruption for CVADs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129062 0
Dr Evan Alexandrou
Address 129062 0
Room 124, Building 41 University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 129062 0
Australia
Phone 129062 0
+61 418 453 650
Fax 129062 0
Email 129062 0
alexandrou@uow.edu.au
Contact person for public queries
Name 129063 0
Dr Evan Alexandrou
Address 129063 0
Room 124, Building 41 University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 129063 0
Australia
Phone 129063 0
+61 418 453 650
Fax 129063 0
Email 129063 0
alexandrou@uow.edu.au
Contact person for scientific queries
Name 129064 0
Dr Evan Alexandrou
Address 129064 0
Room 124, Building 41 University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country 129064 0
Australia
Phone 129064 0
+61 418 453 650
Fax 129064 0
Email 129064 0
alexandrou@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal at the discretion of the Principal Investigator.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Data can be obtained from the Principal Investigator (Dr Evan Alexandrou; alexandrou@uow.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.